Voluntariness of consent in paediatric HIV clinical trials: a mixed-methods, cross-sectional study of participants in the CHAPAS-4 and ODYSSEY trials in Uganda.

Shafic MakumbiFrancis BajunirweDeborah FordAnna TurkovaAnnabelle SouthAbbas LugemwaVictor MusiimeDiana GibbImelda K Tamwesigire

Published in: BMJ open (2024)

This study demonstrated a high voluntariness of consent, which was enhanced among male parents and by parents' trust in medical researchers. Prior research experience of the child and advice from health workers and spouses were negatively associated with the voluntariness of parents' consent. Female parents and parents of children with prior research experience may benefit from additional interventions to support voluntary participation.

Keyphrases

clinical trial
healthcare
mental health
public health
emergency department
antiretroviral therapy
hiv infected
intensive care unit
health information
hepatitis c virus
hiv positive
study protocol
randomized controlled trial
risk assessment
open label
phase ii